Unishield Hand Sanitizer

Product NDC: 49314-0004
11-digit product format: 493140004
Labeler code: 49314
Product ID: 49314-0004_3f97ff59-fdb2-0568-e063-6294a90a3f40
Type: HUMAN OTC DRUG
Nonproprietary name: ETHYL ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Unishield
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-11-15
Substance: ALCOHOL
Active strength: 75 mL/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49314-0004-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49314-0004-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49314-0004-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49314-0004-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49314-0004-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49314-0004-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49314-0004-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49314-0004-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Unishield Hand Sanitizer
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	75 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1305100	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
eae1fc97-eb39-4353-adfa-7c549d50b5db	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49314-0004-1	2025-09-24	C162847	48780-1	2cef2736-a0ef-d83d-e063-dadaa90ab31f	49314-0004 Unishield sanitizer
49314-0004-1	2025-01-30	C162847	48780-1	2cef2736-a0ef-d83d-e063-dadaa90ab31f	49314-0004 Unishield sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49314-0004-1	Unishield Hand Sanitizer	25 in 1 BOX	GEL	25		2
49314-0004-1	Unishield Hand Sanitizer	0.9 mL in 1 PACKET	GEL	0.9		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49314-0004	UNISHIELD HAND SANITIZER (ETHYL ALCOHOL) GEL [UNISHIELD]	1	Current NDC, 2 package rows	20231116_eae1fc97-eb39-4353-adfa-7c549d50b5db.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 28 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cura Hongo Antifungal	CLOTRIMAZOLE	Pharmadel LLC	df031309-2778-00cf-e053-2a95a90a5eea	2025-11-17	Warnings	Exact identifier application number: M005
CharmTex All in One Antibacterial Shave Gel Body Wash	BENZETHONIUM CHLORIDE	Liufangjing Biotechnology (Yangzhou) Co., Ltd	a7433f39-a8d9-4c78-864d-d7ef193a7daf	2025-11-16	Warnings	Exact identifier application number: M005
Mint Blast Foot and Shoe Antifungal	UNDECYLENIC ACID 10%	SANSAR, LLC	f7fcac19-7b72-4b7a-a28e-669a0eebec9c	2025-11-15	Warnings	Exact identifier application number: M005
Lavender Foot and Shoe Antifungal	UNDECYLENIC ACID 10%	SANSAR, LLC	9db58924-a84d-4763-badb-b3aeb46e1ea6	2025-11-15	Warnings	Exact identifier application number: M005
Citrus Detox Foot and Shoe Antifungal	UNDECYLENIC ACID 10%	SANSAR, LLC	6585c9f5-a6cb-4534-9a61-ecbb6dcb7bdc	2025-11-15	Warnings	Exact identifier application number: M005
AlphaTip Nail Repair Pen	NAIL REPAIR PEN	Guangzhou Qiexiran Cosmetics Co., Ltd.	435c7973-8a67-8f51-e063-6394a90af58f	2025-11-11	Warnings	Exact identifier application number: M005
Pharmlitalia Antifungal Medicated Body	TOLNAFTATE	Foshan Sugar Max Cosmetics CO.,Ltd	399302d2-0da4-4167-8884-b34a9aba8686	2025-11-10	Warnings	Exact identifier application number: M005
PerfectHeal Antifungal	CLOTRIMAZOLE	Zhejiang Dingtai Pharmaceutical Co., Ltd	d9750991-8f10-4d6b-8841-bea022d5ad73	2025-11-10	Warnings	Exact identifier application number: M005
PiYanPing Antifungal	MICONAZOLE NITRATE	Zhejiang Dingtai Pharmaceutical Co., Ltd	840364aa-d799-4163-a9e8-3f10c18f86ae	2025-11-10	Warnings	Exact identifier application number: M005
SKINHEAL ANTIFUNGAL	TOLNAFTATE	Zhejiang Dingtai Pharmaceutical Co., Ltd	570ee9fb-a495-4a99-9215-0cd1bb2e0290	2025-11-10	Warnings	Exact identifier application number: M005
HUA TUO XIAN GAO ANTIFUNGAL	CLOTRIMAZOLE	MADISON ONE ACME INC	e11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1d	2025-11-10	Warnings	Exact identifier application number: M005
Selan Antifungal	SELAN ANTIFUNGAL	Trividia Manufacturing Solutions, Inc	8c7e51a0-0cd5-4ae3-a904-fad7ac6c1a29	2025-11-07	Warnings	Exact identifier application number: M005
Fortinia Ultra	CLOTRIMAZOLE 1%	The Podiatree Company	43065a59-fb81-b1c2-e063-6294a90a36e0	2025-11-07	Warnings	Exact identifier application number: M005
MICOCLEAR	CLOTRIMAZOLE ANTIFUNGAL	Rising Pharma Holdings, Inc.	d75b7d3c-3f1c-47e1-8122-4645f56a444e	2025-11-06	Warnings	Exact identifier application number: M005
Medline	MICONAZOLE NITRATE	Medline Industries, LP	1ea444eb-f2f5-8c63-e063-6294a90acac8	2025-11-06	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTIFUNGAL POWDER SPRAY	Premier Brands of America Inc.	38ccf19c-2290-ad99-e063-6394a90a5469	2025-11-06	Warnings	Exact identifier application number: M005
Tolnaftate	ANTIFUNGAL POWDER SPRAY WITH BAKING SODA	Target Corporation	37792b12-c3dc-558f-e063-6294a90a7e75	2025-11-06	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE POWDER SPRAY	Topco Associates LLC	5f8ae9ab-5e34-7a60-e053-2991aa0a9817	2025-11-06	Warnings	Exact identifier application number: M005
Tolnaftate	TOLNAFTATE JOCK ITCH POWDER SPRAY TALC FREE	Topco Associates LLC	5f8ac6b7-c46c-226c-e053-2991aa0a9606	2025-11-06	Warnings	Exact identifier application number: M005
Tolnaftate	ANTIFUNGAL LIQUID SPRAY	Topco Associates LLC	3dd0df06-3c74-4c34-a69e-4240945f5fa5	2025-11-06	Warnings	Exact identifier application number: M005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1305100	ethanol 75 % Topical Gel	PSN	eae1fc97-eb39-4353-adfa-7c549d50b5db	2
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	eae1fc97-eb39-4353-adfa-7c549d50b5db	2
1305100	ethanol 75 % Topical Gel	SY	eae1fc97-eb39-4353-adfa-7c549d50b5db	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
49314-0004-1	49314000401	25 PACKET in 1 BOX (49314-0004-1) / .9 mL in 1 PACKET	25 packet	2023-11-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
49314-0004 Unishield sanitizer	Unishield \| Nantong Health & Beyond Hygienic Products Inc.	2025-09-24	HUMAN OTC DRUG LABEL	2